BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1760409 · Received July 19, 2010

    Report

    Report Number
    2649622-2010-06874
    Event Type
    Death
    Date Received
    July 19, 2010
    Date of Event
    June 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY (B) (4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL AT 4AM ON (B) (6)2010, COLLAPSED, AND RESUSCITATED EXTERNALLY. AT 1306 THAT SAME DAY, THE DEVICE DETECTED A VF (VENTRICULAR FIBRILLATION) AND GAVE THE PATIENT ONE SHOCK. THE PATIENT "WAS ALMOST ON THE VERGE OF DEATH" AT THAT TIME. AT 1314, IT DETECTED VF AGAIN, BUT ABORTED THE SHOCK. THE PATIENT SUBSEQUENTLY DIED. THE PHYSICIAN IS WANTING TO CHECK WHY THE DEVICE WAS "NOT ABLE TO SENSE THE VT/VF WHICH HAPPENED IN THE EARLY MORNING HRS OF (B) (6) 2010." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. IT WAS DETERMINED THE PATIENT WAS NOT PACEMAKER DEPENDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL AT 4AM ON (B)(6) 2010, COLLAPSED, AND RESUSITATED EXTERNALLY. AT 1306 THAT SAME DAY, THE DEVICE DETECTED A VF (VENTRICULAR FIBRILLATION) AND GAVE THE PATIENT ONE SHOCK. THE PATIENT "WAS ALMOST ON THE VERGE OF DEATH" AT THAT TIME. AT 1314, IT DETECTED VF AGAIN, BUT ABORTED THE SHOCK. THE PATIENT SUBSEQUENTLY DIED. THE PHYSICIAN IS WANTING TO CHECK WHY THE DEVICE WAS "NOT ABLE TO SENSE THE VT/VF WHICH HAPPENED IN THE EARLY MORNING HRS OF (B)(6) 2010." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death